Literature update February 2010

Rationale, aims and objectives. Although many believe that evidence-based practice (EBP) has great potential, critics have identified limitations including a focus on randomized clinical trial (RCT) evidence to the exclusion of other evidence types and a disregard for the art of medicine. Others have argued, however, that proper application of EBP involves reasoned consideration of a wide variety of information; thus, the dichotomy between medical science and art may be false. We explore the views of executive-level policymakers from the Veterans Health Administration, a leader in the EBP movement, regarding what constitutes evidence and the relative importance of evidence versus practical needs when determining clinical policy. Method. We conducted 26 semi-structured qualitative interviews and performed a content analysis. Results. Although informants generally believed in the value of EBP and the role of RCTs within it, they also valued other types of evidence. Further, they had concerns that were sometimes antithetical with strict adherence to an evidence-based approach. These included practical concerns, fit with organizational values and with local circumstances, resources, political pressures and patient needs. They were especially concerned about how to address medical conditions that affect many individuals or high-risk populations that have no evidence-based treatment. Conclusion. When possible, health care practice should be evidence-based. When this is not possible, health care providers must turn to the art of medicine by using consensus-based best practices. Further, it is important for policymakers and researchers to work in concert to develop EBPs that are practical and meet needs.

Rationale, aims and objectives. The Appraisal of Guidelines Research and Evaluation (AGREE) instrument is a generic tool for assessing guideline quality. This feasibility study aimed to reduce the ambiguity and subjectivity associated with AGREE item scoring, and to augment the tool's capacity to differentiate between good- and poor-quality guidelines. Methods. A literature review was conducted to ascertain what AGREE instrument adjustments had been reported to date. The AGREE User Guide was then modified by:

constructing a detailed set of instructions, or dictionary, using Boolean operators, and

overlaying seven criteria to categorize guideline quality.

The feasibility of the Boolean-based dictionary was tested by three appraisers using three randomly selected guidelines on low back pain management. The dictionary was then revised and re-tested. Results. Of the 52 published studies identified, 14% had modified the instrument by adding or deleting items and 35% had adopted strategies, such as using a consensus approach, to overcome inconsistencies and ensure identical item scoring among appraisers. For the feasibility test, Pearson correlation coefficients ranged from 0.27 to 0.81. Revision and re-testing of the dictionary increased the level of agreement (range 0.41 to 0.94). Application of the revised dictionary not only decreased the variability of the domain scores, but also reduced the tool's reliability among inexperienced appraisers. Conclusion. Appraisers found the Boolean-based AGREE User Guide easier to use than the original, which improved their confidence in the tool. Good reliability was achieved in the feasibility test, but the reliability and validity of some of the changes will require further evaluation.

Motivating physicians to increase productivity and maximizepatient satisfaction may result in conflicted behavior, raisingquestions about whether one must be sacrificed for the other.To determine if high satisfaction (measured by Press Ganey patientsatisfaction survey) can be achieved while maintaining highproductivity (measured in McGladrey relative value units, MRVU),longitudinal data collected from January 2002 to July 2004 weremodeled using repeated measures regression. A total of 136 000patient-completed satisfaction questionnaires evaluating 417physicians were collected for analysis. Patient confidence (positivelycorrelated; P = .001) and physician/patient time (inverselycorrelated; P = .001) were associated with higher physicianproductivity. Increases in MRVU were associated with decreasesin patient perceptions of time with the physician (P = .003).The relationships between patient satisfaction and physicianproductivity were relatively small, suggesting that they arenot necessarily incompatible and that both can be improved simultaneously.

Problem: System-wide improvement of chronic disease care is challenging because it requires collaboration and communication across organisational and professional boundaries. Managed clinical networks are one potential solution, but there is little evidence of their effectiveness. Design and setting: Retrospective, mixed-methods evaluation of the form and impact of quality improvement in the Tayside Diabetes Managed Clinical Network (MCN) 1998–2005. Strategies for change: Progressive implementation of multiple quality improvement strategies predominately directed at individuals and clinical teams (guideline development and dissemination, education, clinical audit, encouragement of multidisciplinary team working, task redesign). Information technology played an important role in supporting QI activity, but participants identified it as facilitative rather than delivering QI by itself. More important was achieving widespread clinical engagement through persuasion and appeal to shared professional values by clinical leaders. Effects of change: Simple process measures such as glycated haemoglobin measurement rapidly improved. More complex process measures such as eye screening improved more slowly, and were more dependent on redesign of the care pathway. Improvement was greater for type 2 than type 1 diabetes. Significant shifts of care for type 2 diabetes into primary care were achieved, but were harder to achieve without additional resources. Lessons learnt: Delivering better care to whole populations across organisational and professional boundaries required sustained work over long periods, and at all levels of the system of care. Past network focus on clinical collaboration has been effective at improving clinical process and outcome, and the network is now prioritising work with managers and patients to support future redesign.

A better understanding of the needs of patients and their carers can help improve services. Marilyn Kendall and colleaguesdescribe how to conduct multiperspective studies.

Karen Sepucha, Elissa M. Ozanne. How to define and measure concordance between patients’ preferences and medical treatments: A systematic review of approaches and recommendations for standardization. Patient Education and Counseling 2010;78(1) :12-23.

Objective. The purpose is to systematically review the methods used to calculate the association between patients’ preferences and treatment choices and to present a set of recommendations for definition and measurement of this concept. Methods. A systematic review of the literature from 1967 to 2007 identified articles that reported a relationship between patients’ preferences and their treatment choices. Potential citations were identified from electronic databases, the Cochrane Collaborative review, and identified experts. Relevant articles were abstracted by two reviewers independently using standard forms. Results. The search identified 3114 unique citations, the full text of 180 articles was examined, and 49 articles were included. These 49 studies used a variety of definitions of preferences and choices, and calculated concordance in different ways. Half of the studies tied their method to a theoretical framework. There were problems with many of the studies that limit the ability to generalize or make comparisons across studies. Conclusion. There is no consistent method for defining or calculating the match between patients’ preferences and treatment choices. There is a need for more clarity in the definition and reporting of this type of concordance in measures of decision quality. Practice Implications. The match between an informed patient's preferences and treatment choices is a key component of patient-centered care. Valid and reliable measures of the level of concordance are needed.

Extract. Disclosure of financial associations of authors of articles published in biomedical journals has become common practice. The information provided in these disclosures helps the reader to understand the relationships between the authors and various commercial entities that may have an interest in the information reported in the published article. At present, many journals ask authors to report such relationships by completing a form with information about their financial associations. The journals then either post the complete information online or create a summary of the information and publish it with the article in question. Although efforts are under way to establish uniform reporting systems, there is currently no uniform vehicle for the disclosure of financial associations. Thus, authors may need to provide similar information to different journals in multiple formats. In addition, slight differences among journals in requirements for reporting can lead to confusion, as the same individual may report different information to different journals. With this editorial, which is being published simultaneously in all International Committee of Medical Journal Editors (ICMJE) journals, we introduce a new disclosure form that has been adopted by all journals that are members of the ICMJE. We encourage other journals to adopt this reporting format, and we are placing the form in the public domain. We ask authors to disclose 4 types of information. First, their …

Objective To determine the effectiveness and cost effectivenessof using information from circulating biomarkers to inform theprioritisation process of patients with stable angina awaitingcoronary artery bypass graft surgery. Design Decision analytical model comparing four prioritisationstrategies without biomarkers (no formal prioritisation, twourgency scores, and a risk score) and three strategies basedon a risk score using biomarkers: a routinely assessed biomarker(estimated glomerular filtration rate), a novel biomarker (Creactive protein), or both. The order in which to perform coronaryartery bypass grafting in a cohort of patients was determinedby each prioritisation strategy, and mean lifetime costs andquality adjusted life years (QALYs) were compared. Data sources Swedish Coronary Angiography and Angioplasty Registry(9935 patients with stable angina awaiting coronary artery bypassgrafting and then followed up for cardiovascular events afterthe procedure for 3.8 years), and meta-analyses of prognosticeffects (relative risks) of biomarkers. Results The observed risk of cardiovascular events while onthe waiting list for coronary artery bypass grafting was 3 per10 000 patients per day within the first 90 days (184 eventsin 9935 patients). Using a cost effectiveness threshold of £20000-£30 000 (22 000-33 000; $32 000-$48 000) per additionalQALY, a prioritisation strategy using a risk score with estimatedglomerular filtration rate was the most cost effective strategy(cost per additional QALY was <£410 compared with theOntario urgency score). The impact on population health of implementingthis strategy was 800 QALYs per 100 000 patients at an additionalcost of £245 000 to the National Health Service. The prioritisationstrategy using a risk score with C reactive protein was associatedwith lower QALYs and higher costs compared with a risk scoreusing estimated glomerular filtration rate. Conclusion Evaluating the cost effectiveness of prognostic biomarkersis important even when effects at an individual level are small.Formal prioritisation of patients awaiting coronary artery bypassgrafting using a routinely assessed biomarker (estimated glomerularfiltration rate) along with simple, routinely collected clinicalinformation was cost effective. Prioritisation strategies basedon the prognostic information conferred by C reactive protein,which is not currently measured in this context, or a combinationof C reactive protein and estimated glomerular filtration rate,is unlikely to be cost effective. The widespread practice ofusing only implicit or informal means of clinically orderingthe waiting list may be harmful and should be replaced withformal prioritisation approaches.

Patient-centered medical homes (PCMHs) have been endorsed by primary and specialty care medical associations, payers, and patient groups as an innovative structure for transforming health care delivery. The cornerstone principle of the PCMH is the primary care physician's coordination of a patient's use of health care services, including visits to specialists, to improve effectiveness and efficiency. This principle aligns with the vision behind the creation of HMOs, managed care organizations that were once embraced by physicians, patients, and policy analysts but have since lost much of their luster. Many patients and physicians rejected HMOs as too restrictive, objecting particularly to the concept of gatekeeping. This article reviews the HMO experience and identifies lessons applicable to PCMHs that build on the strengths of HMOs while avoiding their mistakes.

Background: Clinical practice guidelines are largely conceived as tools that will inform health professionals’ decisions rather than foster patient involvement in decision making. The time now seems right to adapt clinical practice guidelines in such a way that both the professional’s perspective as care provider and the patients’ preferences and characteristics are being weighed equally in the decision-making process. We hypothesise that clinical practice guidelines can be adapted to facilitate the integration of individual patients’ preferences in clinical decision making. This research protocol asks two questions: How should clinical practice guidelines be adapted to elicit patient preferences and to support shared decision making? What type of clinical decisions are perceived as most requiring consideration of individual patients’ preferences rather than promoting a single best choice? Methods: Stakeholders’ opinions and ideas will be explored through an 18-month qualitative study. Data will be collected from in-depth individual interviews. A purposive sample of 20 to 25 key-informants will be selected among three groups of stakeholders: health professionals using guidelines (e.g., physicians, nurses); experts at the macro- and meso-level, including guideline and decision aids developers, policy makers, and researchers; and patient representatives. Ideas and recommendations expressed by stakeholders will be prioritized by nominal group technique in expert meetings. Discussion: One-for-all guidelines do not account for differences in patients’ characteristics and for their preferences for medical interventions and health outcomes, suggesting a need for flexible guidelines that facilitate patient involvement in clinical decision making. The question is how this can be achieved. This study is not about patient participation in guideline development, a closely related and important issue that does not however substitute for, or guarantee individual patient involvement in clinical decisions. The study results will provide the needed background for recommendations about potential effective and feasible strategies to ensure greater responsiveness of clinical practice guidelines to individual patient’s preferences in clinical decision-making.

Objective. Patient values are not routinely assessed in clinical practice. Adaptive Conjoint Analysis (ACA) is increasingly applied in studies assessing treatment preferences, and could provide a means to routinely assess individual patients’ treatment preferences. Methods. An ACA-questionnaire was administered three times (7–10 days apart) to 98 long-term rectal cancer survivors either on a portable computer or through internet, to assess whether (a) responses differ according to administration mode, (b) relative importances of rectal cancer treatment outcomes (survival, local control, incontinence, sexual problems) consolidate over time, (c) ACA-outcomes are sufficiently reliable (ICC) for use in individual decision-making. We also evaluated patients’ acceptance of ACA. Results. Mode did not affect ACA-completion or evaluation. Importance scores did not consolidate over time. ICCs were poor for sexual problems and fair for the other outcomes, and were at least equal or higher from first to second retest. Most participants valued completing the ACA-questionnaire and learning their results. Conclusion Values did not show consolidation over time. ACA-derived preferences should not determine which treatment patients should choose. Practice implications Findings extend ACA-validation studies to the health care setting and suggest that ACA-questionnaires might be appreciated as adjuncts to treatment decision-making in newly diagnosed patients.

Extract. Many peer reviewed journals now require authors to be preparedto share their raw, unprocessed data with other scientists orstate the availability of raw data in published articles, butlittle information on how such data should be prepared for sharinghas emerged. Iain Hrynaszkiewicz and colleagues propose a minimumstandard for de-identifying datasets to ensure patient privacywhen sharing clinical research data.

Davies P, Walker AE, Grimshaw JM. A systematic review of the use of theory in the design of guideline dissemination and implementation strategies and interpretation of the results of rigorous evaluations. Implementation Science 2010, 5:14.

Background. There is growing interest in the use of cognitive, behavioural, and organisational theories in implementation research. However, the extent of use of theory in implementation research is uncertain. Methods. We conducted a systematic review of use of theory in 235 rigorous evaluations of guideline dissemination and implementation studies published between 1966 and 1998. Use of theory was classified according to type of use (explicitly theory based, some conceptual basis, and theoretical construct used) and stage of use (choice/design of intervention, process/mediators/moderators, and post oc/explanation). Results. Fifty-three of 235 studies (22.5%) were judged to have employed theories, including 14 studies that explicitly used theory. The majority of studies (n = 42) used only one theory; the maximum number of theories employed by any study was three. Twenty-five different theories were used. A small number of theories accounted for the majority of theory use including PRECEDE (Predisposing, Reinforcing, and Enabling Constructs in Educational Diagnosis and Evaluation), diffusion of innovations, information overload and social marketing (academic detailing). Conclusions. There was poor justification of choice of intervention and use of theory in implementation research in the identified studies until at least 1998. Future research should explicitly identify the justification for the interventions. Greater use of explicit theory to understand barriers, design interventions, and explore mediating pathways and moderators is needed to advance the science of implementation research.

Objective To synthesise the views of patients and carers indecision making regarding treatment for chronic kidney disease,and to determine which factors influence those decisions. Design Systematic review of qualitative studies of decisionmaking and choice for dialysis, transplantation, or palliativecare, and thematic synthesis of qualitative studies. Data sources Medline, PsycINFO, CINAHL, Embase, social workabstracts, and digital theses (database inception to week 3October 2008) to identify literature using qualitative methods(focus groups, interviews, or case studies). Review methods Thematic synthesis involved line by line codingof the findings of the primary studies and development of descriptiveand analytical themes. Results 18 studies that reported the experiences of 375 patientsand 87 carers were included. 14 studies focused on preferencesfor dialysis modality, three on transplantation, and one onpalliative management. Four major themes were identified asbeing central to treatment choices: confronting mortality (choosinglife or death, being a burden, living in limbo), lack of choice(medical decision, lack of information, constraints on resources),gaining knowledge of options (peer influence, timing of information),and weighing alternatives (maintaining lifestyle, family influences,maintaining the status quo). Conclusions The experiences of other patients greatly influencedthe decision making of patients and carers. The problematictiming of information about treatment options and synchronouscreation of vascular access seemed to predetermine haemodialysisand inhibit choice of other treatments, including palliativecare. A preference to maintain the status quo may explain whypatients often remain on their initial therapy.

Extract. Studies performed by the World Health Organization (WHO) showthat at least one-third of all disease burden in developed countriescan be attributable to 5 modifiable risk factors: tobacco use,blood pressure level, cholesterol level, obesity, and alcoholuse.1 Patients play a fundamental role in public health as theyultimately make decisions regarding how to lead their lives.These important choices have an impact on their health, theeffectiveness of prescribed treatments, and their use of medicalresources. Therefore, in order to improve the health of patients,the role of health care professionals extends beyond practicingevidence-based medicine to providing patients with an easy-to-understandassessment of their cardiovascular disease risk and the meansto modify their risk. Current guidelines recommend office-based risk stratificationof all individuals using multiple risk factor scores to determineglobal risk. An expanding number of readily accessible assessmentsof . . .

Background: Quality improvement programs that allow physicians to document medical reasons for deviating from guidelines preserve clinicians' judgment while enabling them to strive for high performance. However, physician misconceptions or gaming potentially limit programs. Objective: To implement computerized decision support with mechanisms to document medical exceptions to quality measures and to perform peer review of exceptions and provide feedback when appropriate. Design: Observational study. Setting: Large internal medicine practice. Participants: Patients eligible for 1 or more quality measures. Measurements: A peer-review panel judged medical exceptions to 16 chronic disease and prevention quality measures as appropriate, inappropriate, or of uncertain appropriateness. Medical records were reviewed after feedback was given to determine whether care changed. Results: Physicians recorded 650 standardized medical exceptions during 7 months. The reporting tool was used without any medical reason 36 times (5.5%). Of the remaining 614 exceptions, 93.6% were medically appropriate, 3.1% were inappropriate, and 3.3% were of uncertain appropriateness. Frequencies of inappropriate exceptions were 7 (6.9%) for coronary heart disease, 0 (0%) for heart failure, 10 (10.8%) for diabetes, and 2 (0.6%) for preventive services. After physicians received direct feedback about inappropriate exceptions, 8 of 19 (42%) changed management. The peer-review process took less than 5 minutes per case, but for each change in clinical care, 65 reviews were required. Limitation: The findings could differ at other sites or if financial incentives were in place. Conclusion: Physician-recorded medical exceptions were correct most of the time. Peer review of medical exceptions can identify myths and misconceptions, but the process needs to be more efficient to be sustainable.

The Guidelines International Network is formally constituted as a Scottish Guarantee Company under Company Number SC243691 and recognised as a Scottish Charity under Scottish Charity Number SC034047 with its Registered Office at J. & H. Mitchell W.S., 51 Atholl Road, Pitlochry, Perthshire PH16 5BY, Scotland.